非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.971856471862091861581851571861841858710.25
210.991843831852741848280.35
单位质量响应值RSD%判断
16943.5716817.830.53数据可信
供试品溶液-BXK5AZ2批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min134022-3402218.12519.4811.1018.1219.4811.10
232232-3223217.17117.17
337531-3753119.99419.99
443642-4364223.25023.25
534349-3434918.29918.30
637643-3764320.05420.05
10min172578-7257838.66545.4912.6238.6945.5212.62
277015-7701541.02941.06
382875-8287544.15044.18
4101440-10144054.04154.08
584055-8405544.77944.81
694325-9432550.25050.28
15min1112972-11297260.18468.699.7060.2868.809.71
2119304-11930463.55763.65
3128836-12883668.63568.74
4143201-14320176.28876.42
5125594-12559466.90867.01
6143745-14374576.57876.70
20min1137478-13747873.23978.886.7173.4379.106.71
2139196-13919674.15474.36
3145945-14594577.75077.97
4155327-15532782.74883.00
5146754-14675478.18178.40
6163642-16364287.17887.42
30min1152717-15271781.35887.535.2181.6787.885.22
2159484-15948484.96385.29
3159035-15903584.72385.07
4172810-17281092.06292.46
5167607-16760789.29089.64
6174145-17414592.77393.16
45min1161348-16134885.95690.744.9386.4191.244.94
2160949-16094985.74386.21
3166962-16696288.94689.44
4177764-17776494.70195.25
5174918-17491893.18593.68
6180069-18006995.92996.47
60min1163945-16394587.33991.614.4087.9392.264.41
2164123-16412387.43488.04
3167662-16766289.31989.96
4178964-17896495.34096.05
5176904-17690494.24394.89
6180167-18016795.98196.69
极限1187836-187836100.06799.840.64100.81100.640.65
2186453-18645399.330100.09
3186353-18635399.277100.07
4186284-18628499.240100.10
5188892-188892100.629101.44
6188608-188608100.478101.34
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.971858861856411860831860381853361857970.17
210.991847391848851848120.06
单位质量响应值RSD%判断
16936.8316816.380.51数据可信
供试品溶液-BXK5AZ2批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min123302-2330212.41713.567.0112.4213.567.01
225568-2556813.62413.62
328068-2806814.95614.96
423573-2357312.56112.56
526157-2615713.93813.94
626065-2606513.88913.89
10min166691-6669135.53738.263.8835.5638.283.88
271548-7154838.12538.15
372708-7270838.74338.77
471814-7181438.26738.29
572994-7299438.89638.92
675016-7501639.97340.00
15min194679-9467950.45153.864.3850.5353.944.38
299766-9976653.16253.25
3102137-10213754.42554.51
4100868-10086853.74953.83
5100576-10057653.59353.68
6108415-10841557.77057.86
20min1113117-11311760.27664.214.3360.4464.394.33
2119226-11922663.53163.71
3120983-12098364.46764.65
4121081-12108164.52064.69
5119285-11928563.56363.74
6129317-12931768.90869.09
30min1136906-13690672.95276.853.8473.2277.133.85
2142352-14235275.85476.13
3145077-14507777.30677.59
4143844-14384476.64976.93
5143178-14317876.29476.58
6153931-15393182.02482.33
45min1156477-15647783.38186.843.2283.7787.253.22
2162003-16200386.32586.73
3163318-16331887.02687.44
4162114-16211486.38586.79
5161416-16141686.01386.42
6172495-17249591.91692.35
60min1168919-16891990.01192.632.7490.5493.192.74
2170547-17054790.87891.43
3173359-17335992.37792.94
4171128-17112891.18891.74
5177840-17784094.76495.32
6181235-18123596.57397.16
极限1178846-17884695.30096.671.7095.9897.381.72
2179721-17972195.76796.47
3181181-18118196.54597.26
4181219-18121996.56597.27
5180097-18009795.96796.68
6187431-18743199.875100.63
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.971846621857561849661859231854701853550.29
210.991845101844251844680.04
单位质量响应值RSD%判断
16896.5416785.080.47数据可信
供试品溶液-BXK5AZ2批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14074-40742.1752.3822.972.182.3822.93
24686-46862.5022.50
35926-59263.1643.16
43153-31531.6841.68
55219-52192.7872.79
63681-36811.9661.97
10min114420-144207.7007.3025.447.707.3125.45
219107-1910710.20310.21
315189-151898.1118.12
49148-91484.8854.89
513258-132587.0807.08
610938-109385.8415.84
15min119786-1978610.56610.3421.2410.5810.3621.24
225594-2559413.66713.69
322226-2222611.86911.89
414984-149848.0018.01
518397-183979.8249.84
615212-152128.1238.14
20min122463-2246311.99511.8717.6112.0311.9017.62
227772-2777214.83014.87
325567-2556713.65313.69
418191-181919.7149.74
521371-2137111.41211.44
618029-180299.6279.65
30min126555-2655514.18014.0013.5114.2314.0613.53
231511-3151116.82716.90
328913-2891315.43915.50
422934-2293412.24712.29
525147-2514713.42813.48
622294-2229411.90511.95
45min131092-3109216.60316.039.4816.6816.119.52
232872-3287217.55317.65
333255-3325517.75817.85
427232-2723214.54214.60
529163-2916315.57315.65
626524-2652414.16414.23
60min133456-3345617.86517.486.4217.9717.586.47
235543-3554318.98019.11
334547-3454718.44818.56
431047-3104716.57916.66
531550-3155016.84816.95
630268-3026816.16316.25
极限136691-3669119.59318.605.3819.7318.735.41
237649-3764920.10420.26
333920-3392018.11318.26
433643-3364317.96518.08
534029-3402918.17118.30
633030-3303017.63817.75
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